The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D) supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese adults.
The prevalence of obesity and levels of overweight is rising worldwide. In the United States, 63% of men and 55% of women are now overweight or obese. Recent epidemiological data and clinical trials have shown that a small daily increase in calcium or dairy products may result in annual losses in body weight and body fat. Data from clinical studies suggest that a 1000 mg per day increase in calcium intake is associated with an 8 kg difference in mean body weight and that calcium intake explains about 3% of the variance in body weight. The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D) supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese adults. Otherwise healthy overweight and obese men and women ages 18 to 65 years with a BMI between 25 and 35 kg/m2 will be randomized into one of the following experimental groups (36 in each group): 1. Regular OJ: one 8 fluid oz serving three times/day (control) 2. Regular OJ fortified with Calcium (350 mg/8 fluid oz serving) and Vitamin D3 (100 IU/8 fluid oz serving): one 8 fluid oz serving three times/day (treatment) Subjects will receive either orange juice (OJ) (control) or OJ fortified with calcium and vitamin D3 (treatment) for 16 weeks. The study will involve 6 outpatient study visits to the study center. Primary endpoint: Change in body weight after 16 weeks Secondary endpoint: Visceral fat change after 16 weeks as measured by single slice CT scan
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
Three 240 mL glasses of orange juice fortified with 350 mg Ca and 100 IU of D per serving
Three 240 mL glasses of orange juice without Ca or VitD
Individual and group nutritional counseling by a registered dietitian
Massachusetts General Hospital Weight Center
Boston, Massachusetts, United States
Change in body weight
Time frame: Baseline and 16 weeks
Change in visceral adipose tissue mass
Time frame: Baseline and 16 weeks
Change in subcutaneous adipose tissue mass
Time frame: Baseline and 16 weeks
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